Posted by Michael Wonder on 18 Sep 2020
CHMP recommends approval of Lilly's baricitinib for the treatment of adults with moderate to severe atopic dermatitis
18 September 2020 - Positive opinion is the first regulatory action for baricitinib as an atopic dermatitis medicine.
Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.
